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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1313-6262 | Other Identifier | World Health Organization (WHO) | |
| 2024-520440-42 | Other Identifier | European Medical Agency (EMA) |
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The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0487-0111 | Experimental | Participants will be randomized to receive 1 out of 4 different dose levels subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Placebo | Placebo Comparator | Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0487-0111 | Drug | NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured as percentage of body weight. | From baseline (week 0) to week 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in waist circumference | Measured as centimetre (cm). | From baseline (week 0) to week 84 and week 136 |
| Change in systolic blood pressure (SBP) | Measured as millimetre of mercury (mmHg). |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Broward Research LLC | Recruiting | Miramar | Florida | 33027 | United States | |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Placebo (matched to NNC0487-0111) | Drug | Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
|
| From baseline (week 0) to week 84 and week 136 |
| Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score | Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100. | From baseline (week 0) to week 84 and week 136 |
| Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score | Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate better functional health and well-being. The physical functioning ranges from 19.0 to 57.6. | From baseline (week 0) to week 84 and week 136 |
| Change in body weight | Measured as kilogram (kg). | From baseline (week 0) to week 84 and week 136 |
| Change in body mass index (BMI) | Measured as kilograms per meter squared (kg/m^2). | From baseline (week 0) to week 84 and week 136 |
| Change in IWQOL-Lite-CT physical composite score | Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical composite score ranges from 0-100. | From baseline (week 0) to week 84 and week 136 |
| Change in IWQOL-Lite-CT psychosocial composite score | Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The psychosocial composite score ranges from 0-100. | From baseline (week 0) to week 84 and week 136 |
| Change in IWQOL-Lite-CT total score | Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The total score ranges from 0-100. | From baseline (week 0) to week 84 and week 136 |
| Change in glycated haemoglobin (HbA1c) | Measured as percentage of HbA1c. | From baseline (week 0) to week 84 and week 136 |
| Change in fasting plasma glucose (FPG) | Measured as millimole per liter (mmol/L). | From baseline (week 0) to week 84 and week 136 |
| Ratio to baseline: change in fasting insulin | Measured as ratio. | From baseline (week 0) to week 84 and week 136 |
| Change in diastolic blood pressure (DBP) | Measured as mmHg. | From baseline (week 0) to week 84 |
| Ratio to baseline: change in total cholesterol | Measured as ratio. | From baseline (week 0) to week 84 and week 136 |
| Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol | Measured as ratio. | From baseline (week 0) to week 84 and week 136 |
| Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol | Measured as ratio. | From baseline (week 0) to week 84 and week 136 |
| Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol | Measured as ratio. | From baseline (week 0) to week 84 and week 136 |
| Ratio to baseline: change in non-HDL cholesterol | Measured as ratio. | From baseline (week 0) to week 84 and week 136 |
| Ratio to baseline: change in triglycerides | Measured as ratio. | From baseline (week 0) to week 84 and week 136 |
| Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP) | Measured as ratio. | From baseline (week 0) to week 84 and week 136 |
| Number of treatment emergent adverse events (TEAEs) | Measured as events. | From baseline (week 0) to week 84 and week 140 |
| Number of treatment emergent serious adverse events (TESAEs) | Measured as events. | From baseline (week 0) to week 84 and week 140 |
| Number of TEAEs leading to permanent treatment discontinuation | Measured as events. | From baseline (week 0) to week 84 and week 140 |
| Relative change in body weight | Measured as % of body weight. | From baseline (week 0) to week 136 |
| Clinical Neuroscience Solution |
| Recruiting |
| Orlando |
| Florida |
| 32801 |
| United States |
| Hope Clin Res & Wellness | Recruiting | Conyers | Georgia | 30094 | United States |
| Endeavor Health | Recruiting | Skokie | Illinois | 60077 | United States |
| Midwest Inst For Clin Res | Recruiting | Indianapolis | Indiana | 46260 | United States |
| StudyMetrix Research LLC | Recruiting | City of Saint Peters | Missouri | 63303 | United States |
| New York Gastroenterology Associates | Recruiting | New York | New York | 10075 | United States |
| UNC Eastowne Medical Office | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
| PharmQuest Life Sciences LLC | Recruiting | Greensboro | North Carolina | 27408 | United States |
| Accellacare and KDCILM, LLC | Recruiting | Wilmington | North Carolina | 28401 | United States |
| UPA Ctr Weight and Eating Dis | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Clinical Res Collaborative | Recruiting | Cumberland | Rhode Island | 02864 | United States |
| Medical Uni of SC Charleston | Recruiting | Charleston | South Carolina | 29425 | United States |
| Coastal Carolina Research Ctr | Recruiting | North Charleston | South Carolina | 29405 | United States |
| Hillcrest Clinical Research | Recruiting | Simpsonville | South Carolina | 29681-1538 | United States |
| Amarillo Medical Specialists | Recruiting | Amarillo | Texas | 79124 | United States |
| Velocity Clinical Res-Dallas | Recruiting | Dallas | Texas | 75230-6855 | United States |
| Care United Research, LLC | Recruiting | Forney | Texas | 75126 | United States |
| Washington Cntr Weight Mgmt | Recruiting | Arlington | Virginia | 22206 | United States |
| Health Res of Hampton Roads | Recruiting | Newport News | Virginia | 23606 | United States |
| Selma Medical Associates | Recruiting | Winchester | Virginia | 22601-3834 | United States |
| Rainier Clin Res Ctr Inc | Recruiting | Renton | Washington | 98057 | United States |
| Fundación CESIM | Recruiting | Santa Rosa | La Pampa Province | 6300 | Argentina |
| Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli | Recruiting | Buenos Aires | C1425AGC | Argentina |
| Instituto de Investigaciones Clínicas Córdoba | Recruiting | Córdoba | 5000 | Argentina |
| Sanatorio Esperanza | Recruiting | Esperanza, Santa Fe | S3080BQV | Argentina |
| CIPADI | Recruiting | Godoy Cruz | M5501ARP | Argentina |
| Instituto de Investigaciones Clinicas San Nicolás | Recruiting | San Nicolás | B2900 | Argentina |
| Sydney Clinical Trials | Recruiting | Campbelltown | New South Wales | 2560 | Australia |
| Sydney Cardiometabolic Centre | Recruiting | Liverpool | New South Wales | 2170 | Australia |
| Hunter Diabetes Centre | Recruiting | Merewether | New South Wales | 2291 | Australia |
| Heart of Australia | Recruiting | Chelmer | Queensland | 4068 | Australia |
| HUB - Hôpital Erasme | Recruiting | Brussels | 1070 | Belgium |
| UZA - UZ Antwerpen - Department of Endocrinology | Recruiting | Edegem | 2650 | Belgium |
| Universitair Ziekenhuis Gent | Recruiting | Ghent | 9000 | Belgium |
| UZ Leuven - Endocrinology | Recruiting | Leuven | 3000 | Belgium |
| MECLINAS | Recruiting | Mechelen | 2800 | Belgium |
| AZ Delta - Roeselare | Recruiting | Roeselare | 8800 | Belgium |
| C-Health Partners | Recruiting | Calgary | Alberta | T2V 4J2 | Canada |
| Ocean West Research Clinic | Recruiting | Surrey | British Columbia | V3Z 2N6 | Canada |
| G.A. Research Associates Ltd. | Recruiting | Moncton | New Brunswick | E1G 1A7 | Canada |
| Nova Scotia Hlth Halifax | Recruiting | Halifax | Nova Scotia | B3H1V7 | Canada |
| Milestone Research | Recruiting | London | Ontario | N5W 6A2 | Canada |
| Sanos Clinic - Vejle | Recruiting | Vejle | Region Syddanmark | 7100 | Denmark |
| Sanos Clinic - Gandrup | Recruiting | Gandrup | 9362 | Denmark |
| Steno Diabetes Center Nordjylland | Completed | Gistrup | 9260 | Denmark |
| Gentofte Hospital - Center for Klinisk Metabolisk Forskning | Recruiting | Hellerup | 2900 | Denmark |
| Hillerød Endokrinologisk amb. H0652 | Recruiting | Hillerød | 3400 | Denmark |
| Hvidovre Hospital Endokrinologisk forsknings afsnit 159 | Recruiting | Hvidovre | 2650 | Denmark |
| HOPITAL EUROPEEN GEORGES POMPIDOU_Service de nutrition et diabétologie | Recruiting | Paris | 75015 | France |
| HCL-HOPITAL LYON SUD_Service d'Endocrinologie-Diabète-Nutrition | Recruiting | Pierre-Bénite | 69310 | France |
| CHU NANTES - HOPITAL NORD LAENNEC_Service d'Endocrinologie-Diabétologie-Nutrition | Recruiting | Saint-Herblain | 44800 | France |
| CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE-HOPITAL RANGUEIL-Service de diabétologie et nutrition | Recruiting | Toulouse | 31059 | France |
| CENTRE DE RECHERCHE CLINIQUE PORTES DU SUD_Service d'Endocrinologie-Diabétologie-Maladies Métaboliques | Recruiting | Vénissieux | 69200 | France |
| Herz- und Diabeteszentrum NRW - Bad Oeynhausen | Recruiting | Bad Oeynhausen | 32545 | Germany |
| Zentrum für klinische Studien Südbrandenburg GmbH | Recruiting | Elsterwerda | 04910 | Germany |
| MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien | Recruiting | Fulda | 36037 | Germany |
| SMO.MD GmbH - Zentrum für klinische Studien | Recruiting | Magdeburg | 39120 | Germany |
| Institut für Diabetesforschung Osnabrück | Recruiting | Osnabrück | 49080 | Germany |
| Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann | Recruiting | Witten | 58455 | Germany |
| Fowey River Practice | Recruiting | Fowey | Cornwall | PL23 1DT | United Kingdom |
| The Adam Practice | Recruiting | Poole | Dorset | BH16 5PW | United Kingdom |
| Pickering Medical Practice | Recruiting | Pickering | North Yorkshire | YO18 8BL | United Kingdom |
| The Crouch Oak Family Practice | Recruiting | Addlestone | Surrey | KT15 2BH | United Kingdom |
| The Health Centre | Recruiting | Bradford-on-Avon | BA15 1DQ | United Kingdom |
| EMS Healthcare | Recruiting | Cheshire | CH65 4LE | United Kingdom |
| HMC Health - Heston - The Meadows Centre for Health | Recruiting | Hounslow | TW4 7NJ | United Kingdom |
| Kiltearn Medical Centre | Recruiting | Nantwich | CW5 5NX | United Kingdom |
| Knowle House Surgery | Recruiting | Plymouth | PL5 3JB | United Kingdom |
| Clifton Medical Centre | Recruiting | Rotherham | S65 1DA | United Kingdom |
| Staploe Medical Centre | Recruiting | Soham | CB7 5JD | United Kingdom |
| Albany House Medical Centre | Recruiting | Wellingborough | NN8 4RW | United Kingdom |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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